Safety and Efficacy of Intra-Prostatic Injection of Betamethasone for Refractory Chronic Nonbacterial Prostatitis: A Prospective Cohort Clinical Study.

Abstract

Background: We aimed to assess the safety and effectiveness of TRUS guided betamethasone injections in refractory cases of chronic nonbacterial prostatitis.

Patients and methods: Forty-five patients with refractory CNP were included in a prospective cohort clinical trial. Six injections of betamethasone sodium sulfate were guided by TRUS. After injection: assessment of NIH-CPSI, IPSS, IIEF, GRA and VAS were performed 1, 4, and 12 weeks after injection. Prostatitis symptoms were measured by NIH-CPSI. We considered the minimal clinically important difference (MCID) as a 25% decrease or a six-point reduction from baseline. We considered the MCID of the IIEF to be at least an increase of 4 points. We considered the MCID of the IPSS score to be three points and the MCID for the VAS score to be a 25%-35% change of the initial score. Regarding the global response assessment (GRA), scores 5-7 means significant success rate of perceived treatment.

Results: According to total NIH CPSI score, the success rate of injected cases was 71% after 1 week, dropping to 55.6% after 4 weeks and 44.4% after 12 weeks. According to IPSS questionnaire, the MD (mean difference) is -4.09 ± 3.5, -3.8 ± 3.83 and -3.47 ± 3.92. According to the IIEF questionnaire, the success rate was 22% and 26.7% after 4 and 12 weeks respectively. According to GRA, successful pain control was reported in 82%, 71% and 64.4% after 1, 4 and 12 weeks, respectively.

Conclusion: Intraprostatic betamethasone injection is a simple, safe, and feasible procedure in refractory cases with CNP with predominant pain and urinary symptoms.